BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ BIOPSY VALVE

    MDR report key: 15561951 · Received October 7, 2022

    Report

    Report Number
    3020707080-2022-00001
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    July 20, 2022
    Report Date
    October 7, 2022
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    UDI-DI
    00404450305582
    PMA / PMN Number
    K210625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FUJIFILM MEDWORK CONDUCTED AN INVESTIGATION AND REVIEWED THE BATCH RECORDS WHICH SHOWED NO APPARENT ABNORMALITIES. GIVEN THE LIMITATION OF PRODUCT AVAILABILITY, A FULL EVALUATION WAS UNABLE TO BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED ISSUE IS PRESUMED TO BE AN ISOLATED ISSUE. THERE HAS BEEN NO REPORT OF SIMILAR COMPLAINTS RECEIVED FOR THIS PRODUCT AND NO IMMEDIATE ACTIONS HAVE BEEN ESTABLISHED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM MEDWORK BECAME AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2022, INVOLVING JAZZ BIOPSY VALVE. DURING A DIAGNOSTIC PROCEDURE, PART OF THE VALVE WAS FOUND IN THE PATIENT'S STOMACH AFTER THE FORCEPS WERE INTRODUCED THROUGH THE VALVE. THE PART WAS RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO DEATH REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559939 JAZZ BIOPSY VALVE ENDOSCOPE CHANNEL ACCESSORY ODC FUJIFILM MEDWORK GMBH N/A 22154405 00404450305582

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention